The FDA has rejected Eli Lilly’s application for baricitinib, a once-daily oral medication for rheumatoid arthritis. The agency requested additional clinical trial data to further characterize safety across treatment arms.
Lilly and Incyte had submitted an NDA for baricitinib in January 2016. This January, the FDA extended its review by three months to allow for additional data analyses. Meanwhile, baricitinib was approved in the EU in February.
Lilly and Incyte conducted four Phase III clinical trials that showed improvements with baricitinib treatment. The JAK inhibitor is currently being studied in Phase II trials for atopic dermatitis and systemic lupus erythematosus. A Phase III trial for patients with psoriatic arthritis is expected to begin this year. The companies said they disagree with the FDA’s conclusions, and will schedule a resubmission based on further discussions with the agency.